Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uni-Patch, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
389 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983097 | TENS/FES/NMES ELECTRODES | Uni-Patch, Inc. | 1999-09-17 | 389 | 0 |
| K962910 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIF | Uni-Patch, Inc. | 1996-09-05 | 62 | 0 |
| K962332 | TENS/FES/NMES ELECTRODES | Uni-Patch, Inc. | 1996-07-31 | 44 | 0 |
| K961141 | EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MOD | Uni-Patch, Inc. | 1996-05-10 | 50 | 0 |
| K925466 | CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON | Uni-Patch, Inc. | 1993-08-26 | 301 | 0 |
| K871222 | TANTONE MULTI-DAY #633 TENS ELECTRODE | Uni-Patch, Inc. | 1987-05-29 | 63 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda